Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— MASTER-TBI  

Official title:

Proteomic and Metabolomic Detection and Analysis of Serum From Patients With Acute Severe Traumatic Brain Injury: A Prospective, Multicentered Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05867992
• Other study ID #: LY2024-006
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: RenJi Hospital
• Contact: Zhenghui He, M.D.
• Phone: +8613585916217
• Email: hezhenghui8[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are:

1. Which proteins and metabolites are differently expressed in TBI patients' serum?

2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.

Description:

This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group.

Blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions:

1. Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI)

2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• With traumatic brain injury in 12Hrs for case group, or with traumatic bone fracture in 12 hours for control group.

• The Glasglow Coma Scale ranges in 3-8 for case group.

• Need to have routine laboratory examination of blood sample.

• Patients or agents sign the informed consent.

Exclusion Criteria:

• With bone fracture for case group, or with brain injury for control group.

• Have Orthopaedic history for case group, or have Neurological history for control group.

• Death in 24 hours.

• Immunosuppressed state.

• Severe multiple organ dysfunction.

• With infection.

• Pregnant.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Type of trauma
Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.

Locations

Country	Name	City	State
China	Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of differently expressed proteins in patients' serum detected by proteomic	Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through proteomic mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in serum of severe TBI patients in acute phase.	First 12 hours in the emergency room
Primary	Number of differently expressed metabolites in patients' serum detected by metabolomic	Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in serum of severe TBI patients in acute phase.	First 12 hours in the emergency room